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| ID | Type | Description | Link |
|---|---|---|---|
| No EudraCT: 2008-007725-39 |
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The aim of the study is to assess the therapeutic activity and safety of the combination of Bendamustine and Rituximab in MALT lymphomas.
Primary endpoint:
Secondary endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab and Bendamustine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab and Bendamustine | Drug | Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of assessment is the event-free-survival (EFS) according to the criteria of the International Workshop to Standardize Response Criteria for NHL and Criteria for evaluation of response in NHL | 2 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Include evaluation of the next parameters: Complete and partial remission rates for all patients Response duration for responder patients PFS for all patients Overall survival for all patients Acute and long-term toxicity | 2 years follow-up |
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Inclusion Criteria:
Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site (WHO classification)
Any stage (Ann Arbor I-IV)
The novo disease en any extranodal site. For primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria:
b1. H. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics).
b2. H. pylori-positive cases at diagnosis, who failed antibiotic therapy, including patients with: clinical (endoscopic) and histological evidence of disease progression at any time post H. pylori eradication; stable disease with persistent lymphoma at 1 year post H. pylori eradication; relapse (without H. pylori re-infection), after a remission; patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy)
No evidence of histologic transformation to a high grade lymphoma
Measurable or evaluable disease
Age >18 and <85
ECOG performance status 0-2
Life expectancy of at least 1 year
Written informed consent given according to national/local regulations
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Montalbán, MD | Ramon y Cajal Hospital | Principal Investigator |
| Antonio Salar, MD | Hospital del Mar | Principal Investigator |
| Ana Muntañola, MD | Mutua de Terrassa Hospital | Principal Investigator |
| Mª José Rodríguez, MD | Hospital Universitario de Canarias | Principal Investigator |
| María José Terol, MD | Hospital Clínico de Valencia | Principal Investigator |
| Juan Manuel Sancho, MD | ICO Hospital Germans Trias i Pujol | Principal Investigator |
| Eva Domingo, MD | ICO Hospital Durans i Reynals | Principal Investigator |
| Grande Carlos, MD | 12 de Octubre Hospital | Principal Investigator |
| Carlos Panizo, MD | Clínica Universitaria Navarra | Principal Investigator |
| Miguel Canales, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO-Hospital Germans Trias i Pujol | Badalona | Barcelona | 08918 | Spain | ||
| Hospital del Mar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27029228 | Derived | Salar A, Domingo-Domenech E, Panizo C, Nicolas C, Bargay J, Muntanola A, Canales M, Bello JL, Sancho JM, Tomas JF, Rodriguez MJ, Penalver FJ, Grande C, Sanchez-Blanco JJ, Palomera L, Arranz R, Conde E, Garcia M, Garcia JF, Caballero D, Montalban C; Grupo Espanol de Linfomas/Trasplante de Medula Osea (GELTAMO). First-line response-adapted treatment with the combination of bendamustine and rituximab in patients with mucosa-associated lymphoid tissue lymphoma (MALT2008-01): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2014 Dec;1(3):e104-11. doi: 10.1016/S2352-3026(14)00021-0. Epub 2014 Nov 19. |
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| La Paz Hospital |
| Principal Investigator |
| Raquel Oña, MD | MD Anderson Hospital | Principal Investigator |
| Reyes Arranz, MD | La Princesa Hospital | Principal Investigator |
| Dolores Caballero, MD | Hospital Unisversitario de Salamanca | Principal Investigator |
| José Luis Bello, MD | Complejo Hospitalario Universitario de Santiago | Principal Investigator |
| Joan Bargay, MD | Son Llátzer Hospital | Principal Investigator |
| Luis Palomera, MD | Hospital Clínico de Zaragoza | Principal Investigator |
| Franciaco Javier Peñalver, MD | Fundación Hospital Alcorcón | Principal Investigator |
| Eulogio Conde, MD | Marqués de Valdecilla Hospital | Principal Investigator |
| José Javier Sánchez-Blanco, MD | Morales Meseguer Hospital | Principal Investigator |
| Concepción Nicolás, MD | Central de Asturias Hospital | Principal Investigator |
| Barcelona |
| Barcelona |
| 08003 |
| Spain |
| ICO-Hospital Durans i Reynals | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Mutua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Hospital Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | La Coruña | 15706 | Spain |
| Hospital Fundación Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| Hospital La Princesa | Madrid | Madrid | 28006 | Spain |
| Hospital MD Anderson | Madrid | Madrid | 28033 | Spain |
| Hospital Ramón y Cajal | Madrid | Madrid | 28034 | Spain |
| Hospital 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Son Llátzer | Palma de Mallorca | Mallorca | 07198 | Spain |
| Hospital Morales Meseguer | Murcia | Murcia | 30008 | Spain |
| Clínica Universitaria Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Central de Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital Universitario de Salamanca | Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | Tenerife | 38320 | Spain |
| Hospital Clínico de Zaragoza "Lozano Blesa" | Zaragoza | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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